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Phase I Study of Ropivacaine, Clonidine, and Betamethasone Combination for Sciatic Nerve Block in the Popliteal Region

NCT06781632 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-18

No results posted yet for this study

Summary

This is a national, single-center, dose-escalation Phase I study to investigate the safety, pharmacokinetics, and efficacy of a combination containing Ropivacaine, Clonidine, and Betamethasone (Ropiclobet) in healty volunteers.

After screening and eligibility confirmation, at least 28 participants will receive a sciatic nerve block in the popliteal region with Ropiclobet, followed by pharmacokinetic assessments through blood sampling and monitoring of motor and sensory nerve blocks in the tibial and common peroneal nerves. Safety evaluations, including physical exams, vital signs, ECGs, and sedation scores, will be conducted throughout the study. sensory blocks resolve.

Participants will remain under observation for 48 hours post-procedure and will be discharged once motor and sensory blocks resolve. Follow-up visits will be conducted on Days 10 and 15 on an outpatient basis, with an end-of-study visit planned for Day 30.

The dose-escalation protocol involves administering 5 mL, 10 mL, 15 mL, and 20 mL doses to sequential groups of participants, with safety assessments performed after each dose level before proceeding.

Conditions

  • Healthy
  • Nerve Block

Interventions

DRUG

ropivacaine

Ropivacaine HCl - Betamethasone Sodium Phosphate - Clonidine HCl 5.0/0.4\*/0.015 mg/mL (The solution contains 0.53 mg of betamethasone sodium phosphate, equivalent to 0.4 mg of betamethasone)

Sponsors & Collaborators

  • MonitorCRO

    collaborator INDUSTRY

  • PHARMAFINA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2025-02-20
Completion
2025-04-25

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06781632 on ClinicalTrials.gov